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FDA’s Woodcock to Head Office of Pharmaceutical Quality; New Details Emerge

 
• By Kate Rawson

FDA’s proposed Office of Pharmaceutical Quality will be initially headed by CDER Director Janet Woodcock. OPQ would hold responsibility over the manufacturing quality of a drug or biologics throughout a product’s lifecycle; eight offices will oversee activities from policy development to surveillance.

When the Food & Drug Administration’s proposed Office of Pharmaceutical Quality gets off the ground, it will have a familiar face at the helm: Janet Woodcock.

Woodcock, the long-time director of FDA’s Center for Drug Evaluation & Research, will take on the dual role of head of OPQ to “give it a push” while the CDER office is in its initial launch phase, she said in an

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